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Medical Device Nonvisual Accessibility Act of 2023
12/13/2023, 8:31 AM
Summary of Bill HR 1328
Specifically, the bill mandates that medical devices must have nonvisual accessibility features, such as audible or tactile feedback, to assist individuals with visual impairments in using the devices effectively. This includes features such as voice prompts, tactile buttons, and other mechanisms that allow individuals to navigate and operate the devices without relying on visual cues.
The bill also requires manufacturers to provide documentation in accessible formats, such as braille or audio, to ensure that individuals with visual impairments can easily understand how to use the devices. Additionally, the bill mandates that manufacturers conduct testing with individuals who are blind or visually impaired to ensure that the accessibility features are effective and user-friendly. Overall, the Medical Device Nonvisual Accessibility Act of 2023 seeks to promote inclusivity and ensure that individuals with visual impairments have equal access to medical devices. By requiring manufacturers to incorporate nonvisual accessibility features and provide accessible documentation, the bill aims to improve the overall usability and safety of medical devices for all individuals, regardless of their visual abilities.
Congressional Summary of HR 1328
Medical Device Nonvisual Accessibility Act of 2023
This bill requires certain medical devices with a digital interface to meet nonvisual accessibility standards established by the Food and Drug Administration (FDA).
Specifically, the FDA must establish regulations to require a Class II or Class III medical device with a digital interface to provide a blind or low-vision user access to the same services and information, and generally the same ease of use, as provided to a user who is not low-vision or blind. (The FDA classifies medical devices in three classes. Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk.)
A Class II or Class III medical device that does not meet the nonvisual accessibility standards established under this bill may not be sold. However, the FDA may waive the bill's requirements for a device upon a showing that applying the standards would fundamentally alter the nature of the device or create an undue hardship for the manufacturer. The bill also does not apply to devices that are intended solely for use by a health care provider or in a setting outside the home.
